NIH awards $11.8M for contraceptive clinical trials, extending research through 2026

Contract Overview

Contract Amount: $11,791,957 ($11.8M)

Contractor: Lundquist Institute for Biomedical Innovation AT Harbor-Ucla Medical Center

Awarding Agency: Department of Health and Human Services

Start Date: 2015-09-14

End Date: 2026-12-31

Contract Duration: 4,126 days

Daily Burn Rate: $2.9K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 2

Pricing Type: COST NO FEE

Sector: R&D

Official Description: IGF::OT::IGF CONTRACEPTIVE CLINICAL TRIAL NETWORK - MALE SITES - CONTRACEPTIVE EFFICACY CLINICAL TRIALCONTRACT # HHSN275201300024I/HHSN27500007

Place of Performance

Location: TORRANCE, LOS ANGELES County, CALIFORNIA, 90502

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $11.8 million to LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER for work described as: IGF::OT::IGF CONTRACEPTIVE CLINICAL TRIAL NETWORK - MALE SITES - CONTRACEPTIVE EFFICACY CLINICAL TRIALCONTRACT # HHSN275201300024I/HHSN27500007 Key points: 1. The contract supports a critical area of public health research, focusing on contraceptive efficacy. 2. The duration of the contract, over 11 years, suggests a long-term commitment to this research area. 3. The award was made through full and open competition, indicating a broad search for qualified contractors. 4. The primary contractor, Lundquist Institute, has a history of receiving federal research grants. 5. The contract's value is spread across multiple delivery orders, allowing for phased funding and oversight. 6. The research aims to provide valuable data for public health policy and individual reproductive health decisions.

Value Assessment

Rating: good

The contract value of approximately $11.8 million over its extended period appears reasonable for a multi-year clinical trial network. Benchmarking against similar large-scale, multi-site clinical trials managed by NIH would provide a more precise value-for-money assessment. The 'COST NO FEE' (PT) contract type suggests that the government is reimbursing the contractor for allowable costs incurred, which is common for research and development where final costs can be uncertain. This structure, while not directly incentivizing profit, requires careful monitoring of expenditures.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, meaning that all responsible sources were permitted to submit a bid. The presence of two delivery orders (no: 2) suggests that the initial award may have been for a base period with subsequent options exercised, or that the work is being performed across different phases or sites. The competitive process is expected to yield fair pricing and identify the most capable research institution for this complex trial.

Taxpayer Impact: Full and open competition generally benefits taxpayers by fostering a competitive environment that can lead to more cost-effective solutions and a wider pool of innovative approaches. It ensures that taxpayer funds are used to select the best value provider, rather than being limited to a single source.

Public Impact

The primary beneficiaries are individuals seeking reliable information on contraceptive efficacy, contributing to informed reproductive health choices. The research delivered will generate crucial clinical data on contraceptive methods, potentially influencing future product development and public health guidelines. The geographic impact is national, as the findings from this network are intended for broad dissemination and application. The contract supports scientific and medical workforce development through research positions and collaboration opportunities at the participating sites.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Long contract duration (over 11 years) may present challenges in adapting to evolving research methodologies or unforeseen scientific developments.
The 'COST NO FEE' contract type necessitates robust government oversight to ensure that expenditures remain within budget and are justified.
Reliance on a single primary contractor for a network of sites could pose a risk if the contractor experiences significant operational or financial difficulties.

Positive Signals

Awarded through full and open competition, indicating a thorough vetting of potential contractors.
The contract supports a critical public health initiative with significant potential benefits for reproductive health.
The phased nature of delivery orders allows for incremental funding and performance monitoring.

Sector Analysis

This contract falls within the Research and Development in Biotechnology sector (NAICS 541711), a significant area of federal investment. The National Institutes of Health (NIH) is a primary funder of biomedical research, with annual spending in this sector often in the billions. This specific contract supports clinical trials, a crucial step in translating scientific discoveries into practical health solutions. Comparable spending benchmarks would involve looking at other large-scale, multi-year clinical trial awards managed by NIH or other health agencies.

Small Business Impact

The contract details do not indicate any specific small business set-aside provisions (ss: false, sb: false). The primary contractor, Lundquist Institute, is a research institution. While large research grants and contracts can sometimes involve subcontracting opportunities for specialized services, the primary focus here is on the core research activities. The impact on the small business ecosystem would likely be indirect, depending on whether the prime contractor engages small businesses for support services.

Oversight & Accountability

Oversight for this contract is likely managed by the National Institutes of Health (NIH), the awarding agency. As a research and development contract, oversight would focus on adherence to research protocols, ethical conduct, data integrity, and financial accountability. The 'COST NO FEE' (PT) contract type requires diligent monitoring of expenditures to ensure they are allowable and reasonable. Transparency is typically maintained through periodic progress reports and final study publications. Inspector General jurisdiction would apply to investigations of fraud, waste, or abuse.

Related Government Programs

NIH Contraceptive and Reproductive Health Research
National Center for Health Statistics
Centers for Disease Control and Prevention (CDC) Reproductive Health Programs
National Science Foundation (NSF) Biological Sciences Directorate

Risk Flags

Long contract duration
Cost-reimbursement contract type requires diligent oversight
Potential for scientific obsolescence over extended timeline

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $11.8 million to LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER. IGF::OT::IGF CONTRACEPTIVE CLINICAL TRIAL NETWORK - MALE SITES - CONTRACEPTIVE EFFICACY CLINICAL TRIALCONTRACT # HHSN275201300024I/HHSN27500007

Who is the contractor on this award?

The obligated recipient is LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $11.8 million.

What is the period of performance?

Start: 2015-09-14. End: 2026-12-31.

What is the historical spending pattern for contraceptive clinical trials by the NIH?

The NIH has consistently funded research in reproductive health, including contraceptive development and efficacy trials, for decades. Specific spending on contraceptive clinical trials can fluctuate based on research priorities, funding opportunities, and the pipeline of potential studies. While this $11.8 million contract represents a significant investment, it is part of a broader portfolio of reproductive health research. Analyzing historical NIH budgets and specific program announcements related to contraception would reveal trends in funding levels, the types of research prioritized (e.g., efficacy, safety, new methods), and the number and scale of awards. For instance, periods of increased focus on specific public health challenges or the introduction of new contraceptive technologies often correlate with surges in related research funding.

How does the cost per participant in this trial compare to similar NIH-funded contraceptive studies?

Determining the cost per participant requires access to detailed financial breakdowns within the contract and specific participant enrollment numbers, which are not fully provided in the summary data. However, the total contract value of $11.8 million over its extended duration (potentially spanning many years and involving numerous participants across multiple sites) can be used for a high-level estimation. To benchmark, one would need to identify comparable NIH-funded contraceptive clinical trials, ascertain their total costs, participant numbers, and study durations. Factors influencing cost per participant include the complexity of the trial protocol, the type of contraceptive being studied, the frequency of participant visits, required diagnostic tests, and the geographic locations of the study sites. Without these comparative data points, a precise per-participant cost benchmark is not feasible from the provided information.

What are the key performance indicators (KPIs) used to measure the success of this contraceptive clinical trial network?

The success of this contraceptive clinical trial network would typically be measured by several key performance indicators (KPIs) aligned with research objectives. Primary KPIs would include the efficacy rate of the contraceptive methods under investigation, as determined by pregnancy prevention rates during the trial. Secondary KPIs might involve participant adherence to the study protocol, the incidence and severity of adverse events, and participant satisfaction or retention rates. Methodological KPIs would focus on the timely recruitment of participants, data accuracy and completeness, and adherence to the study timeline. Ultimately, the scientific validity and reproducibility of the findings, leading to peer-reviewed publications and potential impact on public health guidelines or product development, serve as overarching measures of success.

What is the track record of the Lundquist Institute in managing large-scale federal clinical trials?

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center has a history of receiving federal funding, including grants and contracts from agencies like the NIH. Its track record in managing large-scale federal clinical trials would be assessed by reviewing its portfolio of past awards, the complexity and duration of those trials, and their outcomes. Key indicators include successful completion of trial objectives, adherence to regulatory requirements (e.g., FDA), timely reporting of results, and effective management of budgets and personnel. Information on their success in managing multi-site trials, their experience with specific therapeutic areas (like reproductive health), and any history of audit findings or performance issues would be crucial for a comprehensive assessment.

What are the potential risks associated with the long duration of this contract (over 11 years)?

The extended duration of this contract, spanning from 2015 to 2026 (over 11 years), presents several potential risks. Scientific advancements in contraceptive technology or research methodologies could render aspects of the original trial design outdated before completion. Changes in regulatory requirements or ethical considerations over such a long period may necessitate protocol amendments, adding complexity and cost. Furthermore, maintaining consistent funding and institutional commitment over more than a decade can be challenging. There's also a risk of key personnel turnover within the research team, potentially impacting institutional knowledge and project continuity. Finally, long-term contracts can sometimes lead to complacency or reduced agility in responding to emerging scientific questions or challenges.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Solicitation ID: NIHNICHDCRHB201204

Offers Received: 2

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Address: 1124 WEST CARSON ST., TORRANCE, CA, 90502

Business Categories: Category Business, Nonprofit Organization, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $11,791,957

Exercised Options: $11,791,957

Current Obligation: $11,791,957

Actual Outlays: $6,620,608

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Parent Contract

Parent Award PIID: HHSN275201300024I

IDV Type: IDC

Timeline